Off-Label Drug Promotion and the Regulation of the Dy

Off-Label Drug Promotion

The FDA makes it very difficult for drug makers to educate doctors about potential uses for their products other than the uses explicitly approved by the FDA.

Senior Fellow Greg Conko explains.

“No federal statute explicitly forbids manufacturers from promoting or otherwise disseminating information about off-label uses of their drugs and devices. The FDA has, however, extended its authority over product labeling to encompass manufacturers’ speech in other contexts—including print and broadcast advertisements, brochures and pamphlets, websites, conferences and seminars, and face-to-face communication. The agency bars nearly all speech promoting an off-label use regardless of its veracity, and vigorously enforces this restriction even when the information is not being broadcast to lay audiences, but is provided directly to physicians with sophisticated medical training.”

Regulation of the Day

Fellow in Regulatory Studies Ryan Young presents the latest “Regulation of the Day”: a New York labeling requirement for sippy cups. Read here.